- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467544
Reduce Cardiovascular Risk in Women Through Tai Chi Intervention
May 17, 2013 updated by: Virginia Commonwealth University
Exploring the Effects of Tai Chi on Cardiometabolic Risk in Women
Tai chi intervention may lead to relaxation and could potentially reduce the risk of cardiovascular disease.
This project entails a comprehensive and innovative approach for understanding, measuring, and potentially reducing cardiovascular risk in women.
The goal of this area of research is to reduce cardiovascular risk and perhaps reduce illness and death.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular disease (CVD) is the leading cause of death in the United States.
Historically, CVD has been under diagnosed and inadequately treated in women related to issues of gender bias, lack of public and medical awareness of its prevalence, and its unique presenting symptomatology.
Despite increasing awareness, as well as better diagnostics and treatment, women are still more likely than men to present with advanced disease and experience higher CVD-related morbidity and mortality.
Given these facts, prevention of CVD is critical.
Cardiometabolic risk (CMR) is a relatively new term for a set of risk factors that, when viewed together, are indicators of overall risk for developing CVD.
CMR is useful for assessing, modifying, and ultimately preventing the development of CVD.
Prevention of CVD in women may best be achieved by early identification and treatment of evolving CMR.
Central or abdominal obesity, reflecting the presence of visceral adipose tissue and evidenced by increased waist circumference, has been shown to be a significant predictor of CVD.
In this PNI-based model of CMR and fatigue, abdominal adiposity and fatigue are products of allostatic load.
Resulting from cumulative wear and tear, fatigue gives rise to dysregulation of metabolic processes, ultimately resulting in subjective symptomatology and disease risk.
Additionally, fatigue often accompanies metabolic changes, potentiating a trajectory of CMR related to decreased physical activity and self-care.
Tai chi may enhance relaxation and could potentially reduce CMR.
The specific aims of this project are to refine a tai chi intervention using a wait-list pretest-posttest design with repeated measures.
Feasibility and acceptability of the intervention and identification of potential indicators of effectiveness also will be assessed.
Additionally, a PNI-based model of fatigue and CMR will be further refined.
The first aim will be analyzed using a mixed effects model.
The second specific aim, to refine a PNI-based model of fatigue and CMR, will be examined using descriptive statistics, graphical methods and pairwise correlations and, as a second step, variable reduction methods including factor analysis, principle component analysis and canonical correlation analysis.
The project is based on a theoretically and scientifically sound framework to investigate a more comprehensive, sensitive, and innovative model for understanding, measuring, and potentially reducing CMR in women.
With further studies, the goal of this line of research is to reduce CMR and perhaps reduce morbidity and mortality related to CVD.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- premenopausal women
- able to read and speak English
- self-reported histories of CVD in first- or second-degree relatives
Exclusion Criteria:
- previous diagnosis of CVD, DM, uncontrolled or severe hypertension (defined as >180/120),
- LDL-C greater than or equal to 160,
- fasting blood glucose greater than or equal to 126,
- morbid obesity (BMI > 40), or
- unstable major depressive disorder.
- taken corticosteroids within 30 days and 72 hours of inhaled or nasal steroids of data collection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: wait list control group
After completing time three data collection, wait-listed participants will be provided with the complete tai chi intervention (8 weeks).
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Experimental: Tai Chi intervention group
This participant group completes the 8-week tai chi group intervention.
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The 8-week tai chi group intervention will be lead by Project PI.
A focused short form of tai chi involving 12 movements will be used in this project.
Each of 8 weekly 60-minute sessions will begin with a 10-minute guided meditation session.
Movements learned the previous week will be reviewed prior to introducing new movements.
Training DVDs will be produced and provided to participants for weekly and ongoing practice of the techniques.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility and acceptability of the intervention
Time Frame: 8weeks intervention & post-class focus group
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8weeks intervention & post-class focus group
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identify potential indicators of intervention effectiveness (change in PNI measures).
Time Frame: baseline
|
baseline
|
Identify potential indicators of intervention effectiveness (change in PNI measures).
Time Frame: 8 Weeks
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8 Weeks
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Identify potential indicators of intervention effectiveness (change in PNI measures).
Time Frame: 4 Months
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4 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jo Lynne W Robins, Ph.D., Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
October 27, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (Estimate)
November 8, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2013
Last Update Submitted That Met QC Criteria
May 17, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13605
- P30NR011403 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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